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Opioid Painkillers: FDA Now Requires ‘Black Box’ Warning

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Screenshot of FDA website representing FDA black box warning

Drug overdose is the number one cause of accidental death in the United States, with an estimated 47,055 deaths from lethal overdoses in 2014. Opioids represent the bulk of these deaths, with 29,468 deaths (63%) due to prescription opioid painkillers or heroin. State and local governments have been scrambling to take action against opioid abuse in their local communities. Now, the federal government has stepped into the fray to combat prescription pill addiction/abuse. On March 22, the U.S. FDA announced that it would require a “black box” warning on opioid painkillers to alert users to these dangers.

FDA Now Requires a “Black Box” Warning on Opioid Painkillers

The FDA’s announcement comes at a time of great concern about the impact of prescription drug abuse on patients and their families. Additionally, the safety labeling changes will affect all immediate-release opioid pain medications, including oxycodone, hydrocodone, oxymorphone, and tramadol.
The black box warning is the FDA’s strongest level of warning on labels. Specific language on the warning states that these medications significantly increase the risk of misuse, abuse, opioid addiction, overdose, and even death. The warning also informs patients about the risk of harmful drug interactions. These often affect serotonin levels, a neurotransmitter that impacts mood and sleep. Consequently, the resulting “serotonin syndrome” may cause confusion, sweating, irregular heartbeat, headache, and muscle spasms. The black box warning will also highlight the potential effects of prescription painkillers on the endocrine system. Additionally, this includes the possibility of adrenal insufficiency and decreased levels of sex hormones.
Additionally, the warning includes a statement about the dangers of taking immediate-release opioids while pregnant. Chronic maternal use of prescription opioids increases the risk of neonatal opioid withdrawal syndrome, or NOWS, a potentially fatal condition. Neonatal medical professionals have become increasingly aware of this syndrome and have devised some treatments, but patients are often unaware of the specific risks of opioid use on prenatal health.

Intended Benefits of the FDA’s New Black Box Warning

The black box warning goal is to raise awareness about the dangers of opioid abuse and help with opioid addiction. In particular, the black box warning will inform patients about the potential for a life-threatening overdose. Upon getting a prescription filled, the prescription bottle will contain a notification about the black-box warning. Additionally, pharmacists are being asked to provide a thorough medication guide in plain, layperson language to help consumers understand the risk of opioid abuse. However, pharmacists are not strictly required to provide such materials to patients.
Importantly, the new FDA black box policy only affects immediate-release medications, which are typically taken every 4 to 6 hours for acute pain relief. The FDA created a similar warning system in 2013 for extended-release medications, which provide long term pain relief for chronic pain patients. Unfortunately, it is unclear whether the warning system mandated in 2013 has significantly reduced abuse of these extended-release medications.
The FDA also urged manufacturers of generic prescription painkillers to create pills with “abuse-deterrent properties”. Five brand name formulations are currently available in the abuse-deterrent format. These include pills that are difficult to crush or cannot be easily dissolved. Therefore, creating abuse-deterrent drugs may prevent opioid users from snorting or injecting opioids obtained from pills.

Evaluating Federal Efforts to Help with Opioid Addiction

The new FDA policy is only the latest in a series of actions designed to address the prescription opioid problem. Last month, the Centers for Disease Control and Prevention released updated guidelines intended to help physicians decide about opioid painkillers prescriptions. The guidelines called for reduced reliance on opioid medications for long-term, non-cancer pain relief and increased patient education about non-opioid pain relief forms.
Of course, the black box warning and CDC prescribing guidelines are only small steps in the fight against opioid addiction in this country. Preventing new prescription painkiller users from becoming addicted to the drugs will help, but it does nothing to address the people already struggling with prescription pill addiction/abuse. To truly provide help with opioid addiction, we need expanded access to treatments that work. For example, treatments such as medical opiate detox support patients through the withdrawal phase. This allows them to overcome withdrawal symptoms and focus on behavioral, emotional, and psychological treatments that promote healthy, long-term recovery from prescription painkiller addiction.
Opioid Addiction Disease Facts Figures, ASAM. Retrieved on 04/19/2016.
Table 8: Opioids and Analgesics, The Official Website of the Executive Office of Health and Human Services (EOHHS). Retrieved on 04/19/2016.
FDA Opioid Black Box Warning, CNN. Retrieved on 04/19/2016.
CDC Guidelines FDA New Black Box Warning 10 Things To Know, Becker’s ASC. Retrieved on 04/19/2016.
FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose, and death, FDA. Retrieved on 04/19/2016.
Serotonin syndrome, Mayo Clinic. Retrieved on 04/19/2016.

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